International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications from over 55 countries. Consistent with these approvals, Viveve is seeking an Investigational Device Exemption from the U.S. Food and Drug Administration (FDA) to conduct a pivotal study on use of the device for improvement in sexual function. Currently, in the United States, the Viveve System is cleared by the FDA for general surgical procedures for electrocoagulation and hemostasis.

"Viveve Medical Inc. completed a $34.5M public offering of 11.5M shares at $3/share. We believe the net capital raised is sufficient to fund the company through 2019E. . .Viveve announced positive results from a pilot trial study of its cryogen-cooled, monopolar radiofrequency technology for the treatment of stress urinary incontinence."

Brian Marckx, Zacks Small-Cap Research
(2/7/18)

"Last week Viveve Medical Inc. announced that, based on positive results from a small pilot study, it expects to forge ahead with stress urinary incontinence clinical programs, with U.S. and outside of the U.S. registration studies planned. . .supporting clinical evidence from randomized, sham-controlled studies and U.S. Food and Drug Administration marketing approval would significantly increase robustness of the marketing message and overall awareness building potential." -Zacks Small-Cap Research

Jeff Cohen, Ladenburg Thalmann
(2/2/18)

"Viveve Medical Inc. announced its intention to expand the cryogen-cooled monopolar radiofrequency (CMRF) platform into the stress urinary incontinence market; the technology has shown early promise in the market as a result of the outcomes from a 12-month pilot study. The company will continue to collect data of CMRF for patients with mild to moderate stress urinary incontinence through two clinical trial registrations."

"Today, before the market open, Viveve Medical Inc. announced preliminary Q4/17 revenue of approximately $5.1M, up 108% year over year (YOY). . .management introduced 2018 revenue guidance of $22–24M, representing 44–57% YOY growth over preliminary FY17 revenue. . .we would continue to be buyers of the company."

Jeff Cohen, Ladenburg Thalmann
(1/4/18)

"Viveve Medical Inc. announced preliminary Q4/17 and FY17 topline results with revenue of $15.3M for FY17, beating our estimate of $15.2M. . .we believe that it is appropriate to value the company based on its representative peers, and as such, we have determined that its valuation should be approximately six times anticipated revenue during FY21. . .we reiterate our Buy rating and price target of $15."

Brian Marckx, Zacks Small-Cap Research
(1/4/18)

"Viveve Medical Inc. expects to report sales of 80 consoles, including 57 in the U.S., 2,600 consumable treatment tips and total revenue of $5.1M for Q4/17. . .the company also provided initial revenue guidance of $22–24M for 2018. . .the Q4/17 preannouncement and 2018 initial revenue guidance were largely in line with our respective estimates." -Zacks Small-Cap Research

"Subanalysis of Viveve Medical Inc.'s VIVEVE I data showed that patients who underwent a single treatment with the Viveve System experienced greater improvement on all six domains of the sexual functioning FSFI measure versus patients given sham treatment. Improvement (versus sham) on three of the six domains was statistically significant. . .these subanalysis data should provide additional confidence in the eventual success of the company's U.S. Food and Drug Administration pivotal study." -Zacks Small-Cap Research

Brian Marckx, Zacks Small-Cap Research
(11/15/17)

"The 47 U.S. consoles that Viveve Medical Inc. placed in Q3/17 was, by far, the strongest since the domestic launch in Q4/16 and up from 27 in Q2/17 and 29 in Q1/17. The company will build on this early momentum in the U.S. and expects to incrementally increase the size of the sales force, including adding reps during the remainder of 2017." -Zacks Small-Cap Research

Anthony Vendetti, Maxim Group
(11/9/17)

"Viveve Medical Inc.'s Q3/17 revenue of $4.07M, up 120% year over year, was in line with the preannouncement and our estimate of $4.1M and above consensus of $3.71M. . .the company increased the low end of its FY17 revenue guidance to a range of $15–16M, from $14–16M. . .we would continue to be buyers of Viveve after it reported in line Q3/17 results and tweaked 2017 revenue guidance upward."

Jeff Cohen, Ladenburg Thalmann
(11/9/17)

"Viveve Medical Inc. announced Q3/17 revenue of $4.1M. . .[it] increased 120% on an annual basis and 32% sequentially as the company's commercial and clinical activities continue to drive adoption and penetration in the marketplace, particularly in the United States. Viveve raised its outlook for 2017 revenues from $14M to the $15–16M range."

Brian Marckx, Zacks Small-Cap Research
(10/20/17)

"Viveve Medical Inc.'s Q3/17 revenue, expected to come in at approximately $4.1M, compares to our $3.7M estimate. Meanwhile, the company expects to report that there were 60 consoles (geographic breakdown not disclosed) placed and about 2,700 treatment tips sold compared to our 60 (26 U.S., 34 international) and 2,900 estimates." -Zacks Small-Cap Research

Anthony Vendetti, Maxim Group
(10/18/17)

"Today, before the market open, Viveve Medical Inc. announced preliminary Q3/17 revenue of approximately $4.1M, up roughly 122% year over year, relatively in line with our estimate of $4.2M and above consensus of $3.7M. Sixty Geneveve systems shipped in Q3/17, bringing the total commercial installed base to 364 systems; the company also sold approximately 2,700 consumable treatment tips in the quarter."

Brian Marckx, Zacks Equity Research
(8/21/17)

"One of the major operational items of interest since Viveve Medical Inc.'s Q1 update is an agreement with InControl Medical LLC (ICM). . .for VIVE to serve as exclusive distributor of that company's innovative incontinence therapy devices to U.S. healthcare providers. . .ICM's products are the same as VIVE's existing target customers. . .ICM's products should provide a relatively seamless add-to-the-bag opportunity for Viveve's direct reps. . .management further commented that results of the ex vivo study were extremely good , that their meeting with FDA was very successful and that they believe their preclinical protocol will be acceptable by FDA."

Anthony Vendetti, Maxim Group
(8/11/17)

"We believe Viveve Meeical Inc.'s Phase 3 trial is on track for a readout of data in mid-2019, and continue to be encouraged by the strong U.S. sales performance (60% of total systems sold) under its current indication. . .VIVE reported 2Q17 total revenues of $3.08M, up 97.7% y/y. . .gross margin of 40.3%, up 600bps y/y. . .management met with the FDA, and they expect to resubmit the investigational device exemption (IDE) to the FDA by early September. If the protocol is approved, the company should commence the Phase 3 trial by the end of 2017."

Jeff Cohen, Ladenburg Thalmann
(8/11/17)

"We believe that Viveve Medical Inc. is currently in discussion with the agency and that a formal IDE would be submitted in the coming months such that a study (VIVEVE II) would commence in late 2017. . .the study would take approximately 12-18 months in duration and that the company would be able to commercialize under this label in 2H18 or early 2019. The study is likely to enroll approximately 250 with 20 to 25 sites. We believe that this claim would eventually prove to further open up the potential marketplace from aesthetics to also include gynecological physicians."

Brian Marckx, Zacks Equity Research
(7/11/17)

"Viveve Medical Inc. is off to a strong start, we expect domestic sales to accelerate throughout 2017. . .VIVE hopes to eventually gain FDA clearance of the Viveve System for an indication related to the improvement of sexual function. While we had hoped the pivotal study would begin this year, that timeline may now be pushed to 2018 given that FDA recently asked for additional safety related data. . .there's several reasons why we expect international sales to pick
up throughout 2017 including the agreement with their distributor in
China, requiring that company to purchase at least 75 units this year"

Gregory Chodaczek, B. Riley & Co.
(5/12/17)

"Viveve Medical Inc. reported revenue of $3.04MM, $265,000 higher than we had expected. . .for the quarter, the company sold 42 Viveve Systems, 29 of which were sold in the U.S., and 2,200 disposable treatment tips. . .Viveve announced it had received an expanded indication for the Viveve system in South Korea which now includes for the treatment of vaginal laxity. . .the company has regulatory approvals in 54 countries and expects another 14 regulatory approvals by the end of the year."

Jeff Cohen, Ladenburg Thalmann
(5/12/17)

"We reiterate our Buy rating for Viveve Medical Inc. and price target of $22.00 for VIVE. The company has plans for dual pathways into the U.S. marketplace of which the first has been approved. . .the second approach that the company plans to pursue would entail a clinical proven pathway (trial) for approval which would likely be for the treatment of vaginal tissue to improve sexual function. We believe that the company is currently in discussion with the agency and that a formal IDE would be submitted in the coming months such that a study (VIVEVE II) would commence in late 2017."

Anthony Vendetti, Maxim Group
(5/12/17)

"We would continue to be buyers of Viveve Medical Inc. following its seventh consecutive quarter of double-digit revenue growth driven by a successful launch of the U.S. commercialization coupled with reaffirmed guidance. For the quarter, 62% of its better-than-expected sales were attributed to the U.S. market, which was commercialized in late January. . .VIVE expanded its South Korean indication to include vaginal laxity and received regulatory approval in Malaysia. . .we believe management's focus on supporting its commercialization efforts in the U.S., obtaining additional regulatory clearances, and investing in market awareness, should provide the foundation for further growth."

Josh Jennings, Cowen & Co.
(5/3/17)

"Viveve Medical Inc. has immediate access to the burgeoning global market for vaginal rejuvenation. . .it's also within months of starting its VIVEVE II clinical study, which if successful should yield a major commercial advantage in the form of an FDA label to improve female sexual function. We initiate at Outperform, with an $11 price target, representing 4.0 times our 2020 sales forecast."

Brian Marckx, Zacks Small-Cap Research
(2/21/17)

"For Viveve Medical Inc., Q4/16 marked the sixth straight quarter of sequential double-digit percentage increase in revenue growth. It also set new records in both the number of consoles and treatment tips sold. . .we remain very encouraged that this continues to show a significant ramp." -Zacks Small-Cap Research

Jeff Cohen, Ladenburg Thalmann
(2/17/17)

"Viveve Medical Inc. announced financial results from Q4 and full year 2016 and held a conference call to discuss. The company announced revenue of $2.45 million and net loss of $5.8 million and $0.55 per share as compared with consensus of $2.14 million and loss of $5.1 million and $0.48 and our estimates for $2.05 million and loss of $5.3 million and $0.49. . .Q4 revenue increased 226% on an annual basis and 32% equentially as the company’s commercial and clinical activities continue to drive adoption and penetration in the marketplace."

Anthony Vendetti, Maxim Group
(2/17/17)

"We would continue to be buyers of Viveve Medical Inc. following its sixth consecutive quarter of double-digit revenue growth driven by increasing system sales, and disposable treatment tip unit sales that increased more than 300% sequentially. . .VIVE is currently awaiting FDA authorization to begin a study for the indication of improving sexual function. Moreover, in January 2017, it announced regulatory clearances in Columbia, Costa Rica, and Malaysia. . .we believe management's focus on attaining additional regulatory clearances, supporting its global distribution partners, expanding its direct sales force, and investing in market awareness, should position it for continued growth."

Brian Marckx, Zacks Equity Research
(1/30/17)

"Viveve Medical Inc. recently crossed what we characterize as a major milestone with the entry of the Viveve System into the U.S. market and the recent announcement last week that they have begun deployment of their initial domestic sales force. While other energy-based devices targeted to the U.S. vaginal laxity market have preceded Viveve's entry, none are FDA- cleared for an indication related to that use. . .the Viveve System is the only device that has demonstrated significant
efficacy for the improvement in vaginal laxity and/or sexual function."

Brian Marckx, Zacks Equity Research
(11/16/16)

"Viveve Medical Inc.'s randomized clinical study results confirmed earlier findings that Viveve System significantly improves sexual function and reduces vaginal laxity. This marketing study, along with data from previous studies and the recent significantly beefed-up
distribution is expected to help accelerate the roll-out of the Viveve
System. . .Geneveve is now cleared for sale in 49 countries and the company expects to have approval in another two to four by the end of this year."

CapitalCube
(11/14/16)

"Viveve Medical Inc. reports financial results for the quarter ended September 30, 2016. . .VIVE's gross margins widened from 28.60% to 37.37% compared to the same period last year, operating (EBITDA) margins now -248.89% from -528.08%."

Jeff Cohen, Ladenburg Thalmann
(11/14/16)

"Viveve Medical Inc. announced financial results from Q3-2016. . .revenues increased 217% on an annual basis and 19% sequentially as the company's commercial activities continue to gain traction in a variety of worldwide markets with a current base of 162 systems. . .VIVE received 9 regulatory approvals during 2016, which brings
totals to 34 countries, and ongoing efforts in 16 more countries of which at least two more are expected by the end of the year. . .VIVE has plans for dual pathways into the U.S. marketplace of which the first has been approved."

Anthony Vendetti, Maxim Group
(11/11/16)

"3Q16 marked Viveve Medical Inc.'s second quarter of commercial sales in China, and the APAC region continues to exhibit the most strength, followed by the Middle East, Europe, and Latin America, comprising roughly 65%, 25%, 6%, and 4% of sales. . .VIVE received an FDA 510(k) clearance in the U.S., and it has begun commercialization. . .we view the company's recent regulatory clearances as significant milestones (i.e. S. Korea, Brazil, and the U.S.), as approval in these countries represents large market opportunities. . . we believe management's focus should position it for growth."

Brian Marckx, Zacks Equity Research
(10/13/16)

"Viveve Medical Inc. continues to make substantive progress towards their quest to commercialize the Viveve System in the U.S. In late September the company submitted an IDE to FDA seeking approval to commence VIVEVE II, a pivotal U.S.-based study expected to support an eventual regulatory filing seeking clearance for an indication related to improvement in sexual function. . .so assuming FDA concurs with a proposed FSFI endpoint and eventual FDA clearance for the treatment. . .in our opinion, could be a game-changer for Viveve."

Jeff Cohen, Ladenburg Thalmann
(10/7/16)

"Viveve Medical Inc. announced that the Viveve System has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA). . .we had previously expected the clearance to occur during Q4 and towards the end of the calendar year; thus, the slightly earlier-than-expected clearance could bolster Q4 and 2017 revenues beyond our current estimates. . .the company has plans for dual pathways into the U.S. marketplace. Currently Viveve is in discussion with the FDA for a 510(k) clearance."

"Viveve Medical Inc. recently announced that it submitted its investigational device exemption for the U.S. Food and Drug Administration (FDA) under de novo 510(k) to begin a study, which will involve about 250 patients. . .we believe this double-blind, randomized trial has the potential to get FDA approval for something that other companies with devices for vaginal rejuvenation don't have. So we believe that if this 250-patient trial is successful, Viveve could have FDA approval for the treatment of vaginal tissue to improve sexual function in women. That could be a very powerful approval, if Viveve is able to get it. We're estimating in 2018 that Viveve could be the first company to have that approval, which would open up a huge market for Viveve, in our opinion. . .Viveve has the technology. It's putting together a worldwide distribution network. And it has the management team to execute, which is a significant part of any equation of a company that is at the stage of Viveve."
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Jeff Cohen, Ladenburg Thalmann
(9/20/16)

"The Viveve Medical Inc. treatment is a non-invasive solution for vaginal laxity that is performed in less than 30 minutes in a physician’s office, and does not require the use of anesthesia. . .the company has been able to demonstrate successful clinical study results in multiple trials. To date, three human studies have been performed with extremely encouraging results. . .within one month after the Viveve treatment, patients reported a statistically significant improvement in vaginal laxity scores, sexual function and sexual satisfaction scores as compared to pre-childbirth levels. . .the system also demonstrated a strong safety profile throughout the study."

Anthony Vendetti, Maxim Group
(8/12/16)

"We would continue to be buyers of Viveve Medical Inc. following its fourth consecutive quarter of double-digit revenue growth driven by the continued commercialization of the Viveve System in new international markets. . .we view the company's recent regulatory clearances as incrementally positive (i.e. South Korea, Singapore), as approval in these countries represents another large market opportunity in Asia. . .to account for the 2Q16 results, as well as our expectations, we are raising our 2016, 2017, and 2018 revenue estimates to $6.4M, $12.8M, and $21.7M, from $6.0M, $12.3M, and $20.9M, respectively.”

Charles Haff, Craig-Hallum Capital
(8/8/16)

"We expect Viveve Medical Inc. to launch in the U.S. with a 'general' product label in early 2017 but they are also pursuing an expanded label which would allow them to market and sell their product for 'vaginal laxity' or sexual dysfunction. . .given the enormous size of the market opportunity, the elegance of VIVE's solution, and a strong management team that we believe can execute on the opportunity, we see the stock reaching $16 based on the 'general' product label in the U.S. and only 2% penetration of target markets."

Brian Marckx, Zacks Equity Research
(6/22/16)

"VIVEVE Medical Inc.'s randomized clinical study results confirmed earlier findings that Viveve System significantly improves sexual function and reduces vaginal laxity. This marketing study, along with data from previous studies and the recent significantly beefed-up distribution is expected to help accelerate the roll-out of the Viveve System. . .distribution agreement in Brazil, which leads the world in cosmetic surgery, just consummated and could be a particularly strong catalyst in 2016. Next steps are to conduct U.S. study in support of FDA filing study could initiate this year."

Anthony Vendetti, Maxim Group
(6/21/16)

"We would continue to be buyers of Viveve Medical Inc. after a better-than-expected quarter. . .the revenue growth was driven by better than-expected placements of Viveve Systems and sales of disposable treatment tips around the world. . .the company released positive results for VIVEVE I clinical trial, which further ensures efficacy of the Viveve System for the treatment of vaginal introital lexity. . .VIVE may be the first company with an FDA-approved device for the treatment of vaginal tissue . . .VIVE is well-positioned to gain regulatory clearances in additional countries, which should lead to the Viveve System gaining further traction."

Brian Marckx, Zacks Equity Research
(6/15/16)

"In mid-May Viveve Medical Inc. reported financial results for the first quarter ending March 31. Revenue. . .was just a hair shy of $1.3M. This represents sequential growth of 71% and 34x the $38k booked in Q1 of last year. VIVE recognized sales of 33 systems and approximately 480 treatment tips in the most recent quarter. As of the Q1. . .the systems installed base stood at approximately 76 units - which implies the recent placement rate of ~10 units per month is continuing to hold."

Anthony Vendetti, Maxim Group
(4/27/16)

"The positive results of VIVEVE I clinical trial builds upon the two previous clinical studies conducted in the U.S. and Japan to further validate the safety and efficacy of its system for the treatment of vaginal laxity. . .approximately 80% of the active subjects showed a positive change in VSQ score at 6 months. Based on mean VSQ score over time, patients improved significantly, and were able to sustain improvement after a single treatment."

Gregory Chodaczek, Sterne Agee
(4/22/16)

"Viveve Medical Inc. announced positive topline results from its VIveve Treatment of the Vaginal Introitus to EValuate Efficacy (VIVEVE I) clinical study. Based on positive interim results announced in July 2015 of 62 participants, we are not surprised by yesterday's strong results. . .this randomized, single-blinded, sham controlled trial consisted of 155 patients from nine clinical sites in Europe, Canada and Japan, with 103 receiving the active treatment and 52 receiving the sham treatment. Six months after treatment. . .the proportion of patients reporting no vaginal laxity in the active group was 41.7% vs. the sham group of 19.2%."

Anthony Vendetti, Maxim Group
(3/9/16)

"Given that Viveve Medical Inc.'s MonaLisa Touch continues to be a critical driver of top-line growth, the company plans on expanding
its salesforce to 16-20 representatives, from 13, over the next 12 months to bolster distribution efforts. . .the company's entry into women's intimate wellness, Intima builds upon ELOS' CO2RE platform to perform gynecological and genitourinary treatments. . .the recently announced CO2RE Intima laser system should enable ELOS to penetrate the large and growing vaginal rejuvenation market; which, according to VIVE presents a total near-term global market opportunity of $7B over the next four years."

Experts Following This Company

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Investing Highlights

First clinically efficacious technology addressing a $7B market opportunity with limited to no competition

Seasoned medical device executive team with a history of significant successes